ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

NCT03201991 | Completed

• 1 other identifier: STUDY00003843
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS

Outcome Measures

Primary Outcomes (1)

• Change in functional muscle strength

  determine the functional muscle strength of quadriceps femoris muscles before and after 12 weeks of home exercise

  Week 12

Study Arms (1)

Exercise Program

OTHER

Participants will be asked to take part in an exercise program that is focused on quadriceps strengthening.

Other: Resistance Exercise Program

Interventions

Resistance Exercise Program OTHER

The resistance exercise program will involve three sets of 10 repetitions of each exercise in levels 1 and 2 every day. Participants will be given instructions to follow.

Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of possible, probable or definite amyotrophic lateral sclerosis (ALS) based on the revised El-Escorial criteria
• Presence in ipsilateral leg of either weakness in any muscle group or of active denervation by needle electromyography (EMG) which is a surrogate marker of early denervation
• Ipsilateral quadriceps femoris strength: \>=4
• Ambulatory with or without assistance
• Revised ALS Functional Rating Scale (ALSFRS-R) Score \> 30
• Forced expiratory vital capacity (FVC) \>50% of predicted

You may not qualify if:

• ALSFRS-R ≤ 30
• Quadriceps femoris strength \<4
• Unable to walk or uses wheelchair as primary means of mobility
• More than mild atrophy of quadriceps
• Bleeding disorder or uptake of anticoagulants
• Unwilling to comply with exercise and needle muscle biopsy
• Not a good research candidate according to the medical opinion of investigator

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Omar Jawdat, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: May 1, 2017
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

US (1)